Brillphalac 3.335 g/5 ml oral solution

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Lactulose

Tilgængelig fra:

Brillpharma (Ireland) Limited

ATC-kode:

A06AD; A06AD11

INN (International Name):

Lactulose

Dosering:

3.335 g/5ml

Lægemiddelform:

Oral solution

Terapeutisk område:

Osmotically acting laxatives; lactulose

Autorisation status:

Marketed

Autorisation dato:

2016-10-28

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRILLPHALAC 3.335 G/5 ML ORAL SOLUTION
LACTULOSE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist have told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
•
You must talk to your doctor if you do not feel better or if you feel
worse
after several days.
WHAT IS IN THIS LEAFLET
1.
What Brillphalac 3.335 g/5 ml oral solution is and what it is used for
2.
What you need to know before you take Brillphalac
3.
How to take Brillphalac
4.
Possible side effects
5.
How to store Brillphalac
6.
Contents of the pack and other information
1.
WHAT
BRILLPHALAC 3.335 G/5 ML ORAL SOLUTION IS AND WHAT IT IS USED FOR
This medicine contains a laxative called Lactulose. It makes the stool
softer and
easier to pass, by drawing water into the bowel. It is not absorbed
into your
body.
Brillphalac 3.335 g/5 ml oral solution is used to treat constipation
(infrequent
bowel movements, hard and dry stools).
Brillphalac 3.335 g/5 ml oral solution is also used to treat hepatic
encephalopathy (a liver disease causing confusion, tremor, decreased
level of
consciousness including coma). Hepatic encephalopathy can lead to a
hepatic
coma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRILLPHALAC
DO NOT TAKE BRILLPHALAC IF:
•
You are allergic (hypersensitive) to lactulose or any of the other
ingredients of this medicine (listed in section 6)
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•
you suffer from galactosaemia (a severe genetic disorder where you
cannot digest galactose)
•
you suffer from blockage in your gastrointestinal tract (apart from
normal constipation)
•
you suffer from gastrointestinal perforation or risk of
gas

Produktets egenskaber

Health Products Regulatory Authority
22 December 2023
CRN00DWKH
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brillphalac 3.335 g/5 ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains Lactulose 3.335 g.
Excipients with known effect: Also contains small amounts of lactose,
galactose, fructose, tagatose or epilactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear, viscous liquid, colourless or pale brownish yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.) For the treatment of constipation.
2.) For the treatment of hepatic encephalopathy (HE): treatment and
prevention of hepatic coma or precoma
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The Brillphalac may be administered diluted or undiluted. Each dose
may if necessary be taken with water or fruit juices, etc.
Each dose of Brillphalac should be swallowed in one and should not be
kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of
the patient.
In case of single daily dose, this should be taken at the same time,
e.g. during breakfast.
During the therapy with laxatives it is recommended to drink
sufficient amounts of fluids (1.5–2 litres, equal to 6-8 glasses)
during the day.
For Brillphalac in bottles the measuring cup may be used.
For lactulose in 15 ml single dose sachets the corner of the sachet
should be torn off and contents taken immediately.
Dosing in constipation:
Brillphalac may be given as a single daily dose or in two divided
doses, for Brillphalac in bottles the measuring cup may be
used.
After a few days the starting dosage may be adjusted to the
maintenance dose based upon treatment response. Several days
(2-3 days) of treatment may be needed before treatment effect occurs.
_ _
_Brillphalac in bottles:_
STARTING DOSE DAILY
MAINTENANCE DOSE DAILY
Adults and adolescents
15-45 ml, corresponding to 10-30 g lactulose
15-30 ml, corresponding to
10-20 g lactul